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| Sponsored by: |
Central South University |
| Information provided by: | Central South University |
| ClinicalTrials.gov Identifier: | NCT00451399 |
Purpose
Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.
| Condition | Intervention | Phase |
|
Weight Gain |
Drug: metformin Behavioral: lifestyle intervention |
Phase IV |
| ChemIDplus related topics: | Metformin Metformin hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison |
| Estimated Enrollment: | 128 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2006 |
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.128 patients were randomized to one of four 12-week individual treatments: metformin (750mg/day), placebo, lifestyle intervention plus metformin (750mg/day) or lifestyle intervention plus placebo. Medications were provided in double-blind fashion.The assessments include body weight, body mass index, waist circumference, fasting glucose, fasting insulin and insulin resistance index.
Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Hunan | |||||
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | |||||
| Changsha, Hunan, China, 410011 | |||||
| Central South University |
| Study Director: | Jingping Zhao, MD | Central South University |
More Information
| Study ID Numbers: | Jzhao |
| First Received: | March 22, 2007 |
| Last Updated: | October 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00451399 |
| Health Authority: | United States: Food and Drug Administration |
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